A workshop on supporting the implementation of the REACH information requirements for nanomaterials was held at ECHA, the European Chemicals Agency, on 8-9 November 2018.
Because the newly revised REACH Annexes for registration of nanomaterials will soon be adopted and is expected to be fully applied by 1 January 2020, it is necessary to update the REACH guidance documents (first published in 2012, selected updates 2017) for nanomaterials.
The workshop was a preparatory step held before for the formal start of the update of ECHA’s guidance documents for nanomaterials by the process known as Partner Expert Group (PEG). The formal start date depends on the publication of the revised REACH Annexes for nanomaterials in the European Official Journal, which is expected before the end of 2018. Around 55 delegates representing different stakeholders such as industry, Member State authorities, non-governmental organisations (NGOs) participated at the workshop.
What is a REACH guidance document?
A guidance document deals with issues that require interpretation on how stakeholders may fulfil regulatory obligations in a consistent way, for example it identifies what tests may be used for an endpoint.
A guidance document is not legally binding similar to a regulation, for example REACH. However, it is often referred to as soft regulation, and is usually used to ensure consistency and clarity for the assessment of substances.
Other approaches than described in a guidance document may be used when deemed warranted, but a clear justification for the approach is expected.
Guidance documents may be updated in the future pending on scientific and technical developments and experience gained from work on assessment of substances.
Four main areas need new guidance
Currently, the main areas to be updated/developed are:
- Guidance on nanoforms – registration and Substance IDentification (SID) issues
- Guidance on grouping and read‐across
- Guidance on Information Requirements (IR) – environmental endpoints
- Guidance on Information Requirements (IR) – human health endpoints
Participants of the Partner Expert Groups may be officially nominated by industrial associations, Member State Competent Authorities (such as the Swedish Chemicals Agency) or NGO associations. Once the PEGs are established, a draft proposal document for each area will be developed by ECHA and circulated for discussion and revision by the groups.
Normally for this type of work, several commenting and revision rounds are expected, including the need for several virtual and face-to-face meetings. The timeframe for the work will be short as the finally agreed proposals should be adopted by the Commission via CARACAL, Competent Authorities for REACH and CLP, around November 2019. Thereafter, ECHA can publish the updated nanomaterial guidance on their homepage for immediate use.
Source: Gregory Moore, Swedish Chemicals Agency and member of SweNanoSafe’s Expert Panel
- News – European Commission
- COMMISSION REGULATION (EU) amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances
- Appendices to existing guidance: For example, these Appendices explained the issues that are different for Nanomaterials. For instance: Appendix to R7a – specific consideration regarding the information requirements (IR) on granulometry; Appendix to R14 – includes specific consideration regarding exposure assessment for nanomaterials (available devices, measurement strategy etc.).
Chapter R.6: Chapter R.6 of the Guidance on Information Requirements and Chemical Safety Assessment (QSARs and grouping of chemicals).
Version 1 (Published May 2017)
Chapter R.7: Endpoint specific guidance (3 chapters: R.7a, b and c). Version 2 (Published May 2017)
Chapter R.8: Characterization of dose [concentration]‐response for human health. Version 1 (Published May 2012)
Chapter R.10: Dose (concentration)‐ response for environment. Version 1 (Published May 2012)
Chapter R.14: Occupational exposure assessment. Version 1 (Published May 2012)
Practical guide: How to prepare registration dossiers that cover nanoforms – best practice. Version 1 (May 2017)
- Aktuellt / EU:s medlemsländer röstar ja till att anpassa kemikalielagstiftningen till nanomaterial
- Lagar & vägledningar / Kemikalier
- Hur man sammanställer registreringsunderlag över nanoformer: bästa praxis. Version 1 (Maj 2017)
Illustration: DOC RABE Media, Adobe Stock